Lab21 Among First to Offer FDA Approved Companion Diagnostic in the US

Lab21 Limited has announced that its CLIA laboratory in Greenville, South Carolina, has been named as one of nine laboratories in the US to offer the first FDA approved companion diagnostic test to provide guidance for the use of Erbitux® (cetuximab).

Recent FDA approval of the Qiagen therascreen KRAS test, allows it to be used to determine whether patients with metastatic colorectal cancer are suitable for treatment with Erbitux.

The test has been routinely used in Europe since 2008 and is the first KRAS assay to secure FDA approval.

The availability of this test gives healthcare providers an FDA approved test which provides fast, consistent and reliable data to determine optimal treatment for colorectal cancer patients who are candidates for EGFR-targeted inhibitor therapy.

Lab21 has been providing a KRAS analysis service using the assay from its CPA Accredited laboratory in Cambridge, UK for both Amgen and Merck Serono since 2008, and has performed in excess of 6000 tests during this time, including patient samples originating in a number of countries in Europe and the Middle East.

Michael Bolick, President of Lab21 Inc., commented: “Lab21 Inc. is delighted to have launched the therascreen KRAS assay as part of our initial portfolio of molecular diagnostic tests. As the only laboratory in Qiagen’s launch group based in the South-eastern region of the US market, Lab21 is well positioned to be the first provider of this valuable service to the regional cancer community.”

Mike Annable, Divisional Director - Clinical Laboratory, added, “Lab21 has significant clinical experience with the therascreen KRAS assay having been one of the first commercial labs to provide this validated assay in the UK. We have been able to leverage this experience during the laboratory validation of the assay for the US market and we are pleased that Erbitux patients can benefit from this experience.”